Brief Title
Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression
Official Title
Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens
Brief Summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory
may help doctors learn more about changes that occur in DNA and identify biomarkers related
to cancer. It may also help doctors find better ways to treat cancer.
PURPOSE: This research trial studies samples from younger patients with malignant germ cell
tumor progression.
Detailed Description
OBJECTIVES:
- Explore inter-tumoral heterogeneity in DNA methylation by tumor histology.
- Determine the genomic methylation pattern in the tumors.
- Correlate methylation pattern with tumor histology and clinical characteristics.
- Carry out exome capture and massively parallel sequencing on selected germ cell tumors
(GCTs) and matched normal tissue.
- Perform exome capture and Solexa sequencing on a selected set of GCTs.
- Validate candidate mutations in an independent set of tumors.
- Determine the expression profile of mRNAs, lincRNAs and microRNAs in the tumors using
RNA Seq.
OUTLINE: Archived blood and tumor tissue samples are analyzed for genomic methylation
pattern, exome capture and sequencing, and candidate mutations by methylation-specific PCR
techniques, single nucleotide polymorphism (SNP) arrays, and Solexa sequencing methods.
Results are validated by using pyrosequencing assays and primer-extension assays. Methylation
pattern is also associated with each patient's tumor histology and clinical data.
Study Type
Observational
Primary Outcome
Event-free survival
Condition
Childhood Germ Cell Tumor
Intervention
DNA methylation analysis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
90
Start Date
October 2011
Completion Date
May 2016
Primary Completion Date
May 2016
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Tumor and blood specimens from patients registered on the Children Oncology Group
(COG) Germ Cell Tumor Protocols, and from other study sites for non-COG patients,
including Children's Medical Center, Dallas and the Dana-Farber Cancer Institute,
Boston
- Patients' clinical data
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
James F. Amatruda, MD, PhD, ,
Administrative Informations
NCT ID
NCT01433224
Organization ID
AGCT11B2
Secondary IDs
COG-AGCT11B2
Responsible Party
Sponsor
Study Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
James F. Amatruda, MD, PhD, Principal Investigator, Simmons Cancer Center
Verification Date
May 2016